An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+ (ADXS11-001)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Advaxis, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Advaxis, Inc.
ClinicalTrials.gov Identifier:
NCT01116245
First received: April 20, 2010
Last updated: January 18, 2012
Last verified: January 2012
  Purpose

Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.


Condition Intervention Phase
Cervical Intraepithelial Neoplasia
Biological: ADXS11-001 (Lm-LLO-E7)
Drug: Placebo Control
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized, Single Blind, Placebo Controlled Phase 2 Study to Assess the Safety of ADXS11-001 for the Treatment of Cervical Intraepithelial Neoplasia Grade 2/3

Resource links provided by NLM:


Further study details as provided by Advaxis, Inc.:

Primary Outcome Measures:
  • The primary end point will be a histologic determination of whether CIN 2/3 present at entry had regressed. [ Time Frame: 11 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary efficacy endpoints include whether HPV DNA was reduced or eliminated and a comparison of their excised cervical tissue controls to assess the extent of disease in treated vs. untreated patients. [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose
5x10^7 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Biological: ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Experimental: Middle Dose
3.3x10^8 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Biological: ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Experimental: High Dose
1x10^9 cfu x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Biological: ADXS11-001 (Lm-LLO-E7)
ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
Placebo Comparator: Placebo
normal saline x 3 intravenous infusions at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
Drug: Placebo Control
3 intravenous infusions of normal saline at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.

Detailed Description:

Worldwide, many women carry HPV and cervical cancer is the leading cancer killer of women under the age of 50. Although its consequences are considerably less severe in the US, it leads to considerable morbidity. Many published clinical trials describe the immunotherapeutic treatment of early stage, pre-invasive, cervical cancer. It is widely recognized that immunotherapies are most effective in early stage disease because the immune system is least debilitated and disease burden is lowest. Invasive cervical cancer is preceded by a long, slowly progressive, pre-invasive phase termed Cervical Intraepithelial Neoplasia (CIN), which allows for this therapeutic approach. An ideal therapy would result in the remission of CIN 2/3 without damage to cervical tissue. A National Institute of Cancer panel charged with achieving consensus on this issue concluded that a non-surgical medical treatment for this indication would be valuable

The primary objectives of this trial are to test three doses of Lovaxin C to determine if vaccination with Lovaxin C in women with CIN 2/3 for whom surgery is indicated can safely reverse the disease compared to placebo treated control patients.

An earlier Phase 1/2 trial of Lovaxin-C in late stage metastatic cervical cancer used a regimen of two doses given with a 28-day interval. That regimen was shown to be safe and to generate reduction in tumor burdens in some patients. In this trial we will treat earlier stage disease in healthier patients with better immune systems, will use the same and lower doses as given before, but add an additional dosing to the regimen by administering the lowest dose that we assessed previously and by adding a third vaccination to the prior regimen. Unlike the phase 1 trial in which 2 doses were given with a 3 week separation, dosing in the proposed trial will be separated by 4-week intervals.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed CIN 2/3 that requires surgical intervention

Exclusion Criteria:

  • Previous history of listeriosis
  • Steroid use
  • Antibiotic use
  • Negative anergy panel
  • HIV positive
  • Pregnant or actively trying during the treatment period
  • Intercurrent disease
  • Penicillin allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116245

Locations
United States, Arizona
New Horizons Women's Care, LLC Recruiting
Chandler, Arizona, United States, 85224
Contact: Pamela Krametbauer    480-235-3635    pamk@precisiontrials.com   
Principal Investigator: Andrew C Villa, MD         
Precision Trials Recruiting
Phoenix, Arizona, United States, 85032
Contact: Christie McGinnis    602-931-4507    christiem@precisiontrials.com   
Principal Investigator: Steven Wininger, MD         
Arizona OB/GYN Affiliates, PC Recruiting
Phoenix, Arizona, United States, 85016
Contact: Pamela Krametbauer    480-235-3635    pamk@precisiontrials.com   
Principal Investigator: Scott Crawford, MD         
Visions Clinical Research - Tucson Recruiting
Tucson, Arizona, United States, 85712
Contact: Brenda Pollock    215-238-8881      
Principal Investigator: Cynthia C Goldberg, MD         
United States, California
Grossmont Center for Clinical Research Recruiting
La Mesa, California, United States, 91942
Contact: Peggy Smith-Nguyen    215-238-8881      
Principal Investigator: Gioi N Smith-Nguyen, MD         
United States, Florida
Visions Clinical Research Recruiting
Boynton Beach, Florida, United States, 33472
Contact: Gina Parks, ARNP    215-238-8881      
Principal Investigator: Keith A Aqua, MD         
Altus Research Recruiting
Lake Worth, Florida, United States, 33461
Contact: Rossmeri Montalvo    561-641-0404    rmontalvo@altusresearch.com   
United States, Illinois
Center for Women Recruiting
Chicago, Illinois, United States, 60612
Contact: Erin McKeever    312-563-2611    erin.cwr@gmail.com   
Principal Investigator: Barbara Soltes, MD         
United States, Indiana
Indiana University Dept. of OB/GYN Oncology Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Jennifer Vinters    317-944-2654    jmvinter@iupui.edu   
Principal Investigator: Giuseppe Del Priore, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Randy Teeter    718-405-8395    rteeter@montefiore.org   
Principal Investigator: Mark Einstein, MD         
New York Downtown Hospital Recruiting
New York, New York, United States, 10038
Contact: Rosa Reynoso    212-312-5267    rosa.reynoso@downtownhospital.org   
Principal Investigator: Allan Klapper, MD         
United States, Pennsylvania
Temple University Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Sarmina Hassan, MD    215-707-7278    shassan@temple.edu   
Principal Investigator: Stacey Jeronis, MD         
United States, Texas
InVisions Consultants, LLC Recruiting
San Antonio, Texas, United States, 78217
Contact: Gina Edwards    210-216-1049    gedwards1_invision@yahoo.com   
Principal Investigator: Bruce Akright, MD         
InVisions Consultants, LLC- c/o Institute for Women's Health Recruiting
San Antonio, Texas, United States, 78212
Contact: Louann Castro    210-226-9705    lcastro1_invision@yahoo.com   
Principal Investigator: Orlando Suris, MD         
United States, Utah
Wasatch Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Karen George    801-288-0609    kgeorge@wasatchcrc.com   
Principal Investigator: Spencer Colby, MD         
Sponsors and Collaborators
Advaxis, Inc.
  More Information

No publications provided

Responsible Party: Advaxis, Inc.
ClinicalTrials.gov Identifier: NCT01116245     History of Changes
Other Study ID Numbers: Lm-LLO-E7-07
Study First Received: April 20, 2010
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Advaxis, Inc.:
Cervical Intraepithelial Neoplasia Stage 2/3

Additional relevant MeSH terms:
Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Anti-Bacterial Agents
Histamine Antagonists
Histamine H1 Antagonists
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014